The Management of Schizophrenia in Clinical Practice (MOSAIC)

This study is currently recruiting participants.
Verified April 2014 by Genentech
Sponsor:
Information provided by (Responsible Party):
Genentech
ClinicalTrials.gov Identifier:
NCT01746134
First received: December 4, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

This study is a disease-based registry designed to follow patients with a DSM-IV-TR (Diagnostic and Statistic Manual of Mental Disorders, Text Revision) diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder treated in usual care settings for up to 5 years. The registry seeks to describe the course of disease in schizophrenia, including cognitive function and negative symptoms, its treatment, and its burden of disease for participants, caregivers, clinicians, and society as a whole.


Condition
Schizophrenia

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Non-Interventional Registry of Diverse Patients With Schizophrenia Across the Disease Spectrum in Usual Care Settings: Course of Disease, Treatments, and Burden of Illness

Resource links provided by NLM:


Further study details as provided by Genentech:

Primary Outcome Measures:
  • Positive and Negative Symptoms of Schizophrenia (PANSS) [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Clinical Global Impression Schizophrenia Scale (CGI-SCH) [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Cognitive function (Fluency, Digit Symbol-Coding, Trail Making Test) [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Negative Symptom Assessment Scale (NSA4) [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Pharmacologic/behavioural treatments used in usual care settings: intervention [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Pharmacologic/behavioural treatments used in usual care settings: dose [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Pharmacologic/behavioural treatments used in usual care settings: duration [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Personal and Social Performance (PSP) [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Schizophrenia Quality of Life Scale (SQLS) [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Schizophrenia Caregiver Questionnaire [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
  • Maslach Burnout Inventory (MBI) [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 2500
Study Start Date: December 2012
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with schizophrenia, schizoaffective disorder, or schizophreniform across the disease spectrum treated in usual care settings

Criteria

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • DSM-IV-TR diagnosis of schizophrenia, schizoaffective disorder, or schizophreniform disorder
  • Participants presenting with the normal course of care in usual treatment settings
  • Able to read and speak English
  • Able and willing to provide informed consent
  • Able and willing to comply with the study protocol

Exclusion Criteria:

  • Participants enrolled as subjects in clinical trials at registry enrollment
  • Participants anticipating they will be unable to participate in regularly scheduled assessments as per protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01746134

Contacts
Contact: Reference Study ID Number: ML28264 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global.rochegenentechtrials@roche.com

  Show 47 Study Locations
Sponsors and Collaborators
Genentech
Investigators
Study Director: Clinical Trials Genentech
  More Information

No publications provided

Responsible Party: Genentech
ClinicalTrials.gov Identifier: NCT01746134     History of Changes
Other Study ID Numbers: ML28264
Study First Received: December 4, 2012
Last Updated: April 7, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014